CDSCO UID MFG/IVD/2022/000159_05a48e516ab8a2d05c80e44cc7a54717_5dad9451542ec28060d32801fe26a9c0

DURAClone B27 Reagent Kit

Beckman Coulter India Private Limited·Device Class Class B·India CDSCO·Brand: DURAClone B27 Reagent Kit

Registration details

UID: MFG/IVD/2022/000159_05a48e516ab8a2d05c80e44cc7a54717_5dad9451542ec28060d32801fe26a9c0
Device class: Class B
Brand name: DURAClone B27 Reagent Kit
License holder: Beckman Coulter India Private Limited
Approving authority: Karnataka
Product information: The DuraClone B27 reagent is comprised of a two-color, immunofluorescence stain, suitable for detecting the HLA-B27 antigen expression in human whole blood samples using a lyse, no wash protocol on a flow cytometer. This reagent is not intended for use to determine the HLA-B27 tissue group.

Other products from Beckman Coulter India Private Limited

Products from the same license holder (10 products)

Compensation setup Reagent

Brand: ClearLLab Compensation kit

Class C

Reagent for aid to differential diagnosis of hematopoietic neoplasms

Brand: ClearLLab Compensation kit

Class C

Reagent for aid to differential diagnosis of hematopoietic neoplasms

Brand: ClearLLab Compensation kit

Class C

Haematolymphoid malignancies screening Reagent

Brand: ClearLLab Compensation kit

Class C

DxFLEX Flow Cytometer Instrument

Brand: DxFLEX Flow Cytometer Instrument

Class A

DxFLEX Flow Cytometer Instrument

Brand: DxFLEX Flow Cytometer Instrument

Brand: CellaVision DM9600

Class A

CellaVision DC-1

Brand: CellaVision DM9600

Class A

About this record

DURAClone B27 Reagent Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000159_05a48e516ab8a2d05c80e44cc7a54717_5dad9451542ec28060d32801fe26a9c0. This device is marketed under the brand name DURAClone B27 Reagent Kit. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is Karnataka.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.